a) Field of the Invention
This invention relates to a lock which serves as a physical barrier which can prevent a treatment from being administered to a patient or a test being conducted until all necessary recordkeeping has been completed. The combination necessary to open the lock--and thus allow the treatment to be administered or test to be performed--can be determined only if medical personnel properly follow a protocol using a bar code reader which ensures that the patient to whom the item is to be administered is the correct patient and that a complete record of the transaction has been recorded.
b) State of the Art
A chronic problem in hospitals is the failure of medical personnel to accurately and completely record each transaction involving a patient. Without complete records, it is impossible to properly allocate and recover costs of each patient transaction. More importantly, without accurate records, it is impossible to know whether a patient has received the correct medications or other treatments at the correct times and in the correct doses. Medical decision making is thus impaired and patient care is compromised.
Various systems have been proposed to correlate a patient with a particular treatment. Moreover, agencies regulating hospitals such as JCAHO require complete and accurate recordkeeping for accreditation. However, all current systems merely address the problem by simplifying the recordkeeping function, while allowing medical personnel to bypass the recordkeeping function. For example, Clinicom markets an electronic bedside charting system known as Clinicare which uses portable hand-held terminals which transmit data to a wall unit via high-frequency radio waves. Patient data are transmitted via telephone lines to the hospital information system mainframe. Personnel, medications, supplies and patients are provided with bar codes. The system can be used to document every aspect of patient care from recording vital signs to controlling medication administration. However, nothing insures that the system is not simply bypassed.
Clinicom has a number of patents relating to its system. For example, U.S. Pat. No. 4,850,009 relates to a portable hand-held terminal with optical means for sensing bar code indicia and having an integrated keyboard, display and electromagnetic transceiver functions. The terminal is capable of wireless interactive communication with a computer system
PCT Application No. W087/00659 and U.S. Pat. Nos. 4,835,372 and 4,857,716 describe a system for correlating items with patients using a bar code wand having an LCD display and a key pad. The system provides a cross-check to insure that an identified item corresponds to an identified patient and an audit trail of all transactions relating to patient therapy, including staff ID, date, time, etc. The purposes of the system include reduction of paperwork and increase in recordkeeping accuracy. Nothing insures that it is used.
U.S. Pat. No. 4,814,759 describes a display monitor which is wall-mounted in a patient's room and interacts with a data input device such as the hand-held terminal described in U.S. Pat. No. 4,835,372. U.S. Pat. No. Des. 297,939 is directed to the design of a portable hand-held terminal U.S. Pat. No. 4,818,850 describes bar code labels and methods of attachment to medical items so that nurses can scan the code and thereby record and double check the medication and dosage being administered.
U.S. Pat. No. 4,916,441 describes a portable hand-held terminal for use at patient bedsides to reduce paperwork, improve recordkeeping and increase accuracy of medical treatment.
Each of the foregoing systems is designed to increase recordkeeping accuracy by minimizing the amount of manual data input and simplifying the recordkeeping process. Unfortunately, the systems can simply be bypassed and the treatment administered without using the barcoding system at all and thus do not address the fundamental problem of non-compliance by hospital personnel with the recordkeeping requirement, and there can be no certainty that any safety feature associated with the system's use is ever employed in actual practice by busy hospital personnel. The standard of care desired is that these systems be used 100% of the time. Even a small percentage of treatments given without benefit of the system, i.e., without recordkeeping, is very undesirable. There is a need for a system whose use is not normally bypassed even 1% of the time.
Other devices for correlating patient specimens or medications with the correct patient are similarly deficient in that they can be bypassed and the treatment administered without benefit of their use. For example, U.S. Pat. No. 4,476,381 describes an ultraviolet label on which patient identifying indicia are imprinted. Nothing ensures that the system is used or that the hospital personnel responsible for administration of medications perform the necessary correlation prior to administration. The bar code labeling arrangement of U.K. Patent No. 1,419,622 can likewise be bypassed, as can the sample identification system of U.S. Pat. No. 4,678,894.
Locking systems which prevent opening a medication or blood bag without correlating the item with the proper patient have been proposed as a means to ensure that a treatment is correlated with the proper patient. For example, in U.S. Pat. Nos. 4,265,101 and 4,787,222, manually operated combination locks on a blood bag can only be opened if the patient to whom the blood is to be administered has the correct combination attached to him. Canadian Patent No. 1,1187,585 provides a locking system in which the patient and the treatment container have matching machine and man-readable identification codes. A scanning means, such as a wand reader, reads the two codes and, if the codes match, releasing means open the lock. The operator may create a label recording the information concerning the treatment by manually operating a keyboard. Nothing in this system ensures that the recordkeeping is done, is accurate or is complete.
While these locking systems prevent administration of an improper treatment to a patient, they do not address the recordkeeping problem.
In contrast to these prior art systems, the present invention prevents administration of a treatment until a protocol has been followed in which the patient and the treatment have been correlated and an accurate record of the treatment has been made.